BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    SOLEX INTRAVASCULAR HEAT EXCHANGE CATHETER

    K Number: K141139 · Decision Oct 3, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    25
    Applicant Total
    5
    Review Days
    154

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    Basic Information

    Device Name
    SOLEX INTRAVASCULAR HEAT EXCHANGE CATHETER
    K Number
    K141139
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5900
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Zoll Circulation
    Date Received
    May 2, 2014
    Decision Date
    October 3, 2014
    Product Code
    NCX
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NCX System, Hypothermia, Intravenous, Cooling

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    Other Clearances by Zoll Circulation

    K Number Device Name
    K112998 AUTOPULSE RESUSCITATION SYSTEM MODEL 1000
    K101987 COOL LINE CATHETER, MODEL CL-2295A, ICY CATHETER, MODEL IC-3893A AND QUATTRO CATHETER, MODEL IC-4593
    K072527 AUTOPULSE RESUSCITATION SYSTEM, MODEL 100
    K063602 AUTOPULSE RESUSCITATION SYSTEM MODEL100